Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00924807
• Recruitment Status: Terminated
• First Posted: June 19, 2009
• Results First Posted: March 17, 2015
• Last Update Posted: December 11, 2018
• Sponsor: Beth Israel Medical Center
• Collaborator: Bayer
• Information provided by (Responsible Party): Beth Israel Medical Center

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Leuprolide acetate, Bicalutamide, Sorafenib	Phase 1; Phase 2

Detailed Description:

Leuprolide acetate (a luteinizing hormone releasing hormone (LHRH) agonist) and Bicalutamide (an anti-androgen) are hormonal agents which are commonly used to reduce testosterone blood level for prostate cancer treatment. Intensity modulated external beam radiotherapy is a standard treatment for localized prostate cancer. Previous studies have shown that combining hormonal therapy and radiation is more effective than radiation alone. Unfortunately, significant percentages (50-75%) of patients still relapse. Sorafenib reduces the growth of cancer cells and has proven effective in the treatment of solid tumors including kidney and liver cancer. This drug is approved by the FDA for treatment kidney and liver cancer. The study investigators believe that adding sorafenib to standard treatment, comprising hormonal therapy and radiation, might be more effective then standard hormonal therapy.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer
• Study Start Date: September 2008
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Androgen Depr, Radiotherapy, Sorafenib; Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.	Drug: Leuprolide acetate, Bicalutamide, Sorafenib; Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg; Other Names: Leuprolide acetate; Bicalutamide; Sorafenib

Outcome Measures

Primary Outcome Measures :

1. Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer. [ Time Frame: Day 29 and every 2 weeks ]
   Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Secondary Outcome Measures :

1. Biochemical Disease-free Survival [ Time Frame: after 9 months ]
   Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20.
• Age > 18 years.
• Life expectancy of greater than 5 years.
• Patients must have normal organ and marrow function.
• No pelvic lymph node metastases based on pelvic CT scan or MRI.
• No bone metastasis. A whole body bone scan is required to rule out metastatic disease.

Exclusion Criteria:

• Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.
• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.

Contacts and Locations

Locations

United States, New York

St.Luke's-Roosevelt Hospital Center

New York, New York, United States, 10019

Sponsors and Collaborators

Beth Israel Medical Center

Bayer

Investigators

• Principal Investigator: Seth Cohen, MD; St. Luke's-Roosevelt Hospital Center

More Information

• Responsible Party: Beth Israel Medical Center
• ClinicalTrials.gov Identifier: NCT00924807
• Other Study ID Numbers: IRB# 004-08; SR06-959
• First Posted: June 19, 2009
• Results First Posted: March 17, 2015
• Last Update Posted: December 11, 2018
• Last Verified: November 2018

Keywords provided by Beth Israel Medical Center:

Prostate Cancer; Combined Androgen Blockade; Radiotherapy; Sorafenib

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Sorafenib; Leuprolide; Bicalutamide; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Fertility Agents, Female; Fertility Agents; Reproductive Control Agents; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Androgen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists